A new follow-up study to the phase 3 OPTIMUM trial in patients with relapsing multiple sclerosis (MS) has shown that a flat daily dose of 20 mg of ponesimod is effective in reducing the annualized relapse rate (ARR) and the number of combined unique active lesions (CUALs).
The study, published in CPT: Pharmacometrics & Systems Pharmacology, characterized the exposure-response relationship between ponesimod and teriflunomide over 108 weeks.
The study “showed that ponesimod 20 mg/day significantly reduces ARR, the study’s primary endpoint, by 30.5% compared to teriflunomide 14 mg/day,” the authors wrote.
The multicenter, randomized, double-blind OPTIMUM study compared the efficacy, safety, and tolerability of ponesimod with those of teriflunomide in 1133 patients with relapsing MS.
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In this study analyzing the exposure-response relationship between the drugs, patients were randomized to receive ponesimod or teriflunomide. The primary endpoint was ARR over the study period, and the secondary endpoint was the number of CUALs from study initiation to week 108.
The results showed that ponesimod treatment at 20 mg once per day led to a significant reduction in ARR compared to teriflunomide, and this in turn led to reduced CUALs compared to teriflunomide.
Patient characteristics such as sex, age, weight, and race did not influence the magnitude of the effect of CUALs on ARR; thus, the authors do not recommend any dose adjustments based on these characteristics and suggest a flat 20-mg daily dose for all adults with MS.
Valenzuela B, Olsson Gisleskog P, Poggesi I, et al. An exposure-response analysis of ponesimod clinical efficacy in a randomized phase III study in patients with relapsing multiple sclerosis. CPT Pharmacometrics Syst Pharmacol. Published online September 1, 2022. doi:10.1002/psp4.12778